It is important for sutures to be easily and quickly supplied to sterile or scrubbed personnel working in a sterile field of use. Typically what is considered to be a sterile field is a designated area in which everything to be touched or used in surgery or a medical procedure is to remain sterile. It is important that the sterile personnel working in the sterile field do not contaminate the field by touching unsterilized packages. Therefore any suture packaging transferred into the sterile field must be sterile.
It is also important that once in the sterile field, a sterile user, can easily and quickly ready the sutures for use without compromising suture sterility.
In packaging absorbable sutures, it is important to provide a barrier to moisture and oxygen and prevent the moisture and oxygen from entering the package. It is well known that water will react with absorbable suture material to cause the polymer structure to break down. Even minute amounts of water or moisture can accelerate absorbable suture degradation. Some stability studies have indicated oxygen also may cause suture degradation.
In the packaging of hydrophilic nylon sutures, the sutures are pre-moistened and packaged in a humid environment so that the nylon material will remain pliable. It is important to provide a barrier to moisture to prevent the moisture from escaping the packaging. Thus a similar packaging is used for pre-moistened nylon sutures as is used for absorbable sutures.
Presently, both absorbable sutures and pre-moistened nylon sutures are packaged in foil and have a secondary plastic and paper overwrap. In the existing art, the foil packaging for absorbable and pre-moistened nylon sutures is made from two or more sections of foil having a polymer lamination or coating to enhance the ability of the foil to act as a sufficient barrier to moisture and oxygen. It is believed that the intimacy of the bonds of the lamination or coating with the foil plays a significant role in closing off voids in the foil. An example of polymer laminated foil suture packaging is described in U.S. Pat. No. 4,014,433.
In the prior art, the foil laminates, i.e., the foil sections with a coating and/or lamination, are heat-sealed together around their periphery forming a heat-seal around a cavity in which the sutures are contained. The process of packaging the sutures is performed in a sterile environment and the outside of the foil is sterilized as well. The secondary wrap is placed over the foil packaging to preserve the sterility of the outside of the foil packaging.
In use, the secondary wrap is typically opened or peeled apart by a non-sterile user such as a circulating nurse whose responsibility it is to get supplies and transfer them to a desired area, usually a sterile field in which surgery or a medical procedure is being performed. The non-sterile user transfers the contents of the secondary wrap by either flipping or dropping the contents, i.e., the foil packaged sutures, onto a sterile tray, or by passing the foil packaged sutures into the sterile field by peeling open the package, exposing and presenting the sterile foil package which a sterile user may then remove, e.g., by grasping with sterile forceps. The flipping, dropping or otherwise passing the secondary wrap contents may be referred to as "transferring." Once the foil package has been transferred into the sterile field, the sterile user may open the sterile foil package and, may grasp the suture needle with an attached suture.
The purpose of the secondary wrap is to enable the non-sterile user to transfer the foil packaging without touching it or otherwise compromising its sterility. It has been important for the peelable secondary packaging to have the right touch, i.e., not to require excessive force to open, so that the user has control of the transferring process, for example, to prevent the inner package component such as a tear-open foil package contained therein, from unintentionally falling out or flying away.
One of the reasons the packaging system using a foil package with a secondary wrap has been considered necessary is, if the foil were not sterile on the outside and were opened by a non-sterile user, unsterile foil, e.g., a torn or peeled outside edge, could come in contact with the suture holding mechanism or the suture and thereby compromise suture sterility.
One of the problems with the existing suture packaging is that the sterile user must open the foil package. This task can be time consuming, awkward, and inconvenient particularly in the context of surgery where a sterile user is involved in several simultaneous activities and may also be required to act quickly.
It is an object of the present invention to eliminate the use of foil suture packaging in the sterile field and to eliminate the secondary overwrap by providing a peelable foil suture package for transferring an immediately accessible suture into the sterile field. Another object of the invention is to reduce the amount of packaging material thus reducing the amount of medical waste material by eliminating the overwrap and using peelable foil to transfer a suture. Another object of the invention is to provide a sterile user easy access to a suture needle and attached suture without requiring the sterile user to peel or tear open a foil package.
Existing peelable foil suture packaging does not provide adequate barrier to moisture to prevent suture degradation for a desirable suture stability and/or is not suitable for transferring sutures into a sterile field.
It is therefore another object of the invention to provide absorbable suture packaging which provides a sufficient barrier to bacteria and moisture while facilitating a relatively easy transfer into a sterile field and easy access by a user.
It is a further object of the invention to provide a peelable foil suture package for hydrophilic nylon sutures packaged under humid conditions that is capable of preventing loss of suture moisture.
It is also an object of the present invention is to provide a peelable foil which reduces the likelihood that the user may be cut by edges of the foil packaging.